MR-based Models for Clinically Significant Portal Hypertension in Cirrhosis (CHESS1802)

Not Applicable

Completed

• Conditions: Hypertension, Portal
• Interventions: Procedure: Transjugular HVPG measurement; Procedure: MR imaging

• Registration Number: NCT03766880
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

Clinically significant portal hypertension (CSPH) is associated with an incremental risk of esophageal varices and overt clinical decompensations in cirrhosis. However, hepatic venous pressure gradient (HVPG) measurement, the gold standard for defining CSPH (HVPG≥ 10mmHg) is invasive and therefore not suitable for routine clinical practice.

This is a multi-center diagnostic trial conducted at high-volume liver centres designed to determine the accuracy of MR-based models (investigational technology) for noninvasive detection of a CSPH in patients with cirrhosis. Transjugular HVPG measurement by means of catheterization of a hepatic vein with a balloon catheter is the gold-standard method to assess the presence of CSPH.

Detailed Description

Clinically significant portal hypertension (CSPH) is associated with an incremental risk of esophageal varices and overt clinical decompensations in cirrhosis. However, hepatic venous pressure gradient (HVPG) measurement, the gold standard for defining CSPH (HVPG≥ 10mmHg) is invasive and therefore not suitable for routine clinical practice.

This is a multi-center diagnostic trial conducted at high-volume liver centres (Zhongda Hospital, Medical School of Southeast University; Affiliated Lishui Hospital of Zhejiang University; Shandong Provincial Hospital affiliated to Shandong University; Beijing 302 Hospital; Xingtai People's Hospital; Shunde Hospital, Southern Medical University; The First Hospital of Zhengzhou University; Shanghai Public Health Clinical Center, Fudan University; The First Hospital of Lanzhou University; Nanfang Hospital of Southern Medical University; Ankara University School of Medicine) designed to determine the accuracy of MR-based models (investigational technology) for noninvasive detection of a CSPH in patients with cirrhosis. Transjugular HVPG measurement by means of catheterization of a hepatic vein with a balloon catheter is the gold-standard method to assess the presence of CSPH.

Study Timeline

• Study Start: 2018-12-04
• Study First Submitted: 2018-12-04
• Study First Submitted QC: 2018-12-04
• Study First Posted: 2018-12-06
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-26
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

• Age 18-75 years
• With written informed consent
• Confirmed liver cirrhosis based on liver biopsy or clinical findings
• Scheduled to undergo clinically-indicated transjugular HVPG measurement by means of catheterization of a hepatic vein with a balloon catheter
• Has undergone> MR imaging within 14 days to hepatic vein catheterization
• No hepatic-portal vein interventional therapy between MR imaging and hepatic vein catheterization

Exclusion Criteria

• A contraindication to MR imaging, in particular pacemakers or implantable defibrillators, cochlear implants, neurosurgical clips, intra-orbital or brain metallic foreign bodies, endo prothesis since less than 4 weeks or osteosynthesis material since less than 6 weeks
• Unable to comply with breathing or other imaging related instructions resulting in inability to obtain diagnostic quality MR imaging studies
• Contraindication to the injection of contrast agent: pregnancy, lactation, history of allergic reaction to contrast agent injection.
• Prior transjugular intrahepatic portosystem stent-shunt surgery
• Prior devascularization operation
• Has received a liver transplant
• Any active, serious, life-threatening disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm study	MR imaging	Participants will receive MR imaging, transjugular HVPG measurement, and analysis per protocol.
Single arm study	Transjugular HVPG measurement	Participants will receive MR imaging, transjugular HVPG measurement, and analysis per protocol.

Primary Outcome Measures

Name	Time	Method
Diagnostic Performance of MR-based Models	1 day	Accuracy, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of MR-based models for noninvasive detection of CSPH when compared to HVPG as the reference standard.

Trial Locations

Locations (11)

Beijing 302 Hospital; 🇨🇳 Beijing, Beijing, China

The First Hospital of Lanzhou University; 🇨🇳 Lanzhou, Gansu, China

Nanfang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

Xingtai People's Hospital; 🇨🇳 Xingtai, Hebei, China

Shunde Hospital, Southern Medical University; 🇨🇳 Shunde, Guangdong, China

Ankara University School of Medicine; 🇹🇷 Ankara, Turkey

The First Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Shanghai Public Health Clinical Center, Fudan University; 🇨🇳 Shanghai, Shanghai, China

Shandong Provincial Hospital affiliated to Shandong University; 🇨🇳 Jinan, Shandong, China

Affiliated Lishui Hospital of Zhejiang University; 🇨🇳 Lishui, Zhejiang, China

Zhongda Hospital, Medical School of Southeast University; 🇨🇳 Nanjing, Jiangsu, China